A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity

NCT06564441 | Completed Phase 1 FDA Drug

• 3 other identifiers: 1404-00082024-512332-29-00U1111-1307-0132
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This study is open to adults with overweight or obesity who are otherwise healthy. People can join the study if they have a body mass index of 27 to 39.9 kg/m2 and a body weight over 70 kg. The purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of bupropion, caffeine, and midazolam in the blood. The study has 2 treatment periods. In Period 1, participants take 1 dose each of midazolam, caffeine, and bupropion as tablets or oral solution on separate days. In Period 2, participants get BI 456906 as an injection under the skin once a week. At 2 selected timepoints in Period 2, participants also take midazolam, caffeine and bupropion as tablets or oral solution on separate days. Participants are in the study for about 13 months. They visit the study site up to 45 times. At 3 of those visits, participants stay for 5 or 6 days at the study site. During the visits, doctors collect information about participants' health and take blood samples from the participants. They compare the amounts of midazolam, caffeine, and bupropion in the blood in Period 2 with the amounts in Period 1. Doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (6)

• Area under the concentration-time curve of bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)

  Up to week 32

• Area under the concentration-time curve of the caffeine in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)

  Up to week 32

• Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞)

  Up to week 32

• Maximum measured concentration of bupropion in plasma (Cmax)

  Up to week 32

• Maximum measured concentration of caffeine in plasma (Cmax)

  Up to week 32

• Maximum measured concentration of midazolam in plasma (Cmax)

  Up to week 32

Study Arms (1)

All participants

EXPERIMENTAL

In Period 1: Bupropion, Caffeine, Midazolam are given as a reference treatment. In Period 2: Survodutide, Bupropion, Caffeine, Midazolam are given as a test treatment.

Combination Product: Survodutide; Drug: Bupropion; Drug: Caffeine; Drug: Midazolam

Interventions

Bupropion DRUG

Bupropion

Also known as: Wellbutrin® XR

All participants

Caffeine DRUG

Caffeine

Also known as: Coffeinum® N

All participants

Midazolam DRUG

Midazolam

Also known as: Midazolam Accord®

All participants

Survodutide COMBINATION_PRODUCT

Survodutide, pre-filled syringe

Also known as: BI 456906

All participants

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Otherwise healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 60 years (inclusive) at signing of informed consent
• Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive) and body weight \> 70 kg
• Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial, i.e. prior to starting any screening procedures legislation prior to admission to the trial, i.e. prior to starting any screening procedures

You may not qualify if:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and in particular:
• Alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20%,
• Aspartate aminotransferase (AST) above ULN + 20%,
• Gamma-Glutamyl-Transferase (GGT) above ULN + 20%,
• Lipase or amylase above ULN + 20%,
• Estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73 m².
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Overweight; Obesity

Interventions

BI 456906; Bupropion; Caffeine; Midazolam

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial consists of two periods in a fixed sequence: period 1 (reference treatment) followed by period 2 (test treatment) within the BI 456906 titration scheme.

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 21, 2024
• Study Start: October 1, 2024
• Primary Completion: December 16, 2025
• Study Completion: January 5, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)